Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around
Principal Investigator
by Maheswari Senthil, MD (uci)

Description

Summary

This is a pilot, single-arm, open label study to evaluate the ability of CYTALUX™ (pafolacianine) to help identify cancerous lesions in subjects with gastrointestinal cancers and peritoneal carcinomatosis during cytoreductive surgery.

Official Title

A Pilot Study of Pafolacianine Injection for Intraoperative Imaging of Gastrointestinal Cancer Peritoneal Carcinomatosis

Keywords

Gastrointestinal Cancer, Peritoneal Carcinomatosis, Gastrointestinal Neoplasms, Carcinoma, Peritoneal Neoplasms, Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging, Pafolacianine (CYTALUX)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Adult patients 18 years of age and older
  • Have a primary diagnosis of primary gastrointestinal cancer (of adenocarcinoma), planned for cytoreductive surgery
  • Female patients must have a negative serum pregnancy test at screening, followed by a negative urine pregnancy test on the day of scheduled study drug infusion, or day of surgery
  • Female patients of childbearing potential, or less than two (2) years postmenopausal, agree to use an acceptable form of contraception from time of signing informed consent until 30 days after study completion
  • Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to abide by study restrictions

You CAN'T join if...

  • Previous exposure to CYTALUX™ (PAFOLACIANINE)
  • Patients with known gastrointestinal cancer with carcinomatosis determined pre-operatively to be inoperable
  • Any medical condition that in the opinion of the investigators could potential jeopardize the safety of the patient
  • History of anaphylactic reaction
  • History of allergy to any components of CYTALUX™ (PAFOLACIANINE), including folic acid
  • Pregnancy, or positive pregnancy test
  • Clinically significant abnormalities on ECG
  • Impaired renal function defined as eGFR <50 mL/min/1.73m2
  • Impaired liver function defined as values >3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin
  • Received an investigational agent in another trial within 30 days prior to surgery
  • Known sensitivity to fluorescent light

Location

  • Chao Family Comprehensive Cancer Center, University of California, Irvine
    Orange California 92868 United States

Lead Scientist at University of California Health

  • Maheswari Senthil, MD (uci)
    Clinical Professor, Surgery, School of Medicine. Authored (or co-authored) 90 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT06511037
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 10 study participants
Last Updated